harnessing social media for pharmacovigilance...harnessing social media monitoring for...
TRANSCRIPT
Harnessing Social Media Monitoring for Pharmacovigilance
Laura Calao Jean Christophe Lahary
2LexisNexis – The Information Specialists
1. Pharmacovigilance in a nutshell
2. Social media monitoring and
pharmacovigilance
• Why take an interest?
• What are the concrete benefits?
3. Social media monitoring – Best practices
4. Questions & answers
Agenda
3LexisNexis – The Information Specialists
What is pharmacovigilance?
• Improving the care given to patients and patient management
•Keeping patients safe while using medication and during medical and paramedical procedures
Patients
•Protecting the health and safety of communities in the use of medicationPublic health
•Taking part in an assessment of the benefits, harmfulness, effectiveness and risks of medicinesRisk assessment
•Promoting knowledge and medical training and encouraging communication intended for (and between) healthcare professions and the general public
Communication
“the science and activities
related to the detection,
assessment, understanding
and prevention of adverse
drug effects or any other
possible drug-related
problems”
--WHO
4LexisNexis – The Information Specialists
1995: Founding of the EMA
2004: Regulation 726/2004
2010: Directive 2010/84/EU
2012: New European directive with
regulation 1235/2010 and directive
2010/84/EU
2016: Work on the role of social media and
the Internet
1963: First pharmacovigilance centre founded at the
16th assembly of the WHO
1906: Founding of the FDA
1938: Federal Food, Drug and Cosmetic Act
1962: Kefauver-Harris amendment
1997: Erice declaration
2014: Draft of the directive on social media
A strict regulatory framework
5LexisNexis – The Information Specialists
Intense pressure from the media
6LexisNexis – The Information Specialists
Examples for pharmaceutical market exits
7LexisNexis – The Information Specialists
5% of feedback comes from the patients
A subject that remains complex
• Globalisation of production, distribution and consumptionGlobalisation
• Uncontrolled sale of drugsE-commerce
• Change in practices and uses within societySafety and openness
• Promoting good practices and sharing of information between stakeholdersEducation
• Control of interactions and surveillanceDeveloping generic products
• Disparity in pharmacovigilance practicesEmerging countries
• New vigilance directivesSocial media
8LexisNexis – The Information Specialists
Social media monitoringWhat for?
What are the benefits?
9LexisNexis – The Information Specialists
Content created every 60 seconds
10LexisNexis – The Information Specialists
The Internet has changed our relationship with health
44% 43% 42% 40% 37% 36% 36%
40% 38% 35% 37% 35% 34% 35%
Positive
Negative
Care receivedat hospital/ medicalfacility
Experiencewithmedication/ treatment
Health insurercustomerservice
Specificdoctor, nurse, healthcareprovider
Cost of healthinsurance
Coverage by health insurer
Cost of care ata hospital/ healthcare provider
*Consumers responding likely or very likely to share an experience using social mediaN = 1060Source: PwC HRI Social Media Consumer Survey, 2012
Likelihood of sharing positive and negative health experiences via social media*
11LexisNexis – The Information Specialists
• Better knowledge of product benefits and risks
• Improved strategies for risk evaluation
• Faster identification and communication of potential risks
• Optimised communication in the event of a crisis, incorrect
information about a product or detection of potential risks
• Better educating healthcare professionals and customers
• Improving relations between pharmaceutical companies,
laboratories and patient communities
PV and SMM: similar bases
12LexisNexis – The Information Specialists
Actual conversations about what is being said of a brand,
a competitor, or even a treatment area or a drug.
Indirect and unguided conversations. Unlike in a
conventional study, nobody guides the conversation. It is
spontaneous.
Millions of opinions can be heard in real time. The
quantity of information available and the speed at which the
information is accessed will never be possible in
conventional studies.
It is possible to detect weak signals and track opinion-
formers, critics and whistle-blowers
Benefits compared to “conventional” sources of information
13LexisNexis – The Information Specialists
Social media monitoringChallenges and good practices to
apply
14LexisNexis – The Information Specialists
Understanding the working of Social Media Monitoring
USUAL
CONVERSATIONSQuestions, histories, crises,
products, services, events,
campaigns, disasters, etc.
SOCIAL
MEDIATOOLS
SOCIAL MEDIA MONITORING (SMM)
DASHBOARDFLOW OF ACTIVITY & CONVERSATIONS
EXTRACTION OF
INFORMATIONDATA AGGREGATION
ENHANCEMENT &
STANDARDISATION
15LexisNexis – The Information Specialists
CollectionWhich data? Which sources?
ProcessingWhich
technologies? What enhancement?
Analysis Which know-how?
Key stages to control
16LexisNexis – The Information Specialists
Use good expertise
17LexisNexis – The Information Specialists
Do not get your
sources wrong,
because your
conclusions will be
incorrect as well.
Monitoring Twitter is
not enough...
Go beyond known SM
Rheumatoid
arthritis
Diabetes
18LexisNexis – The Information Specialists
Summary of good practices
Monitor your regulatory environment1Look out for whistle-blowers and weak signals2Do not stop at automatic analyses3Pay attention to methodologies4Use good expertise and train up your providers5
Thank you for your attention
Laura CalaoLexisNexis
Jean Christophe LaharyLexisNexis